NZ doctors speaking out with science: a brave new declaration by NZ doctors and concerned citizens.
Simon Thornley, Gerhard Sundborn.
12 April 2021
We are usually supporters of vaccines, and our children are all immunised.
Yet we have deep unease that the least tested vaccine in living memory, for a virus posing little risk to most people, has been purchased at great cost, and is being commended to New Zealanders as “safe and effective”.
When Covid Plan B opposed the elimination strategy a year ago, it was not because of doubts over vaccines. We said the strategy was too costly to pursue while waiting for a vaccine. We said that most solutions were likely to be unwarranted by the small danger posed by SARS-CoV-2.
The early development of vaccine-like products is a triumph of science.
Plan B had worried that vaccines would take years to pass the usual safety and effectiveness tests. We hadn’t counted on the panic being so strong that usual stages would be curtailed.
The speed, haste, and enthusiasm with which covid-19 vaccines have been thrust upon us has made us pause and examine the evidence.
New Zealand has purchased enough of the Pfizer mRNA vaccine for everyone in the country. Several other supply arrangements exist in case one falls through.
We do not know the cost of the vaccines, as it has been hidden from us. Sources overseas indicate the cost to governments of the Pfizer/BioNTech vaccine as US$19.50/dose – or NZ$27.63 at current exchange rates. So for 10 million doses, NZ may have paid NZ$276 million.
That doesn’t include the costs of distribution, cold-chain, quality control and administration of the jab.
Is this vaccine worth the cost? What is the evidence for the vaccine’s benefit and are there any potential downsides?
A primary factor in whether a vaccine is warranted for a particular disease in pre-covid times has rested on three principal factors. These are, among others:
- Benefits for high-risk individuals compared to the whole population.
- Healthcare system and societal costs incurred by vaccination programmes compared to treating disease.
- Life years and quality adjusted life years gained because of vaccines.
The World Health Organization has released criteria which focus on clinical consequences, such as safety and efficacy, but also encompass other areas such as public health benefits such as the reduction of infection rate.
The document mentions the ‘preferred’ need for at least 70% vaccine efficacy, with consistent results in the elderly. 50% efficacy is considered minimal. The endpoint may be a combination of disease, severe disease, and or shedding or transmission. The document says 6 months of protection may be acceptable, but one year is preferable.
The WHO discussion of vaccine safety is vague. It says a ‘highly favourable benefit to risk profile’ is ideal, but the benefits outweighing the safety risks is ‘acceptable’.
A footnote mentions that the ‘potential for enhanced disease’ should be considered. Clearly, authors of the document are cognisant of the potential for antibody dependent enhancement, a phenomenon present for other viruses such as dengue, Zika, Ebola and other coronaviruses. This occurs when high antibody concentrations are initially effective against a pathogen, but waning immunity and lower concentrations paradoxically enhance the severity of infection.
The true cost of the epidemic is hard to pin down, and we’re yet to see a formal cost-benefit analysis of the effects of the vaccine, since the long-term effects of the product are unknown.
The main choice facing New Zealanders now is whether to be vaccinated with the Pfizer one, so we’ll focus on this. The main evidence relating to this vaccine is outlined in the New England Journal of Medicine. The trial randomly allocated ~40,000 participants, roughly half each into vaccinated and placebo groups and followed them for two months to see whether they developed covid-19 infection. The study excluded people under the age of 16, pregnant women and people with a history of either covid-19 or any immunocompromising condition. The primary outcome was defined by a positive PCR test, with at least one symptom of infection.
The headline results were 169/20,172 covid-19 events in the placebo group, compared to just 9/19,965 in the vaccine group, giving an efficacy of 94.6% after two months. The most reported side effects from the vaccine were transient, such as fatigue, headache, and muscle pain. The two-month trial did not address viral transmission nor long-term safety and effect.
The trial has come under scrutiny for unexplained incongruities. Further documentation has revealed that the rate of ‘suspected, but not confirmed’ covid-19 were similar between the two groups: with 1,594 cases in the vaccinated and 1,816 in the placebo.
There was also an imbalance in exclusions due to unexplained ‘protocol deviations’. In the vaccinated group 311 were excluded, compared to only 60 in the placebo. The chances of being excluded from the trial were therefore (311/21,720)/ (60/21,728) = 5.2 times higher in the vaccinated group, a ratio which is extremely unlikely to be due to chance (P < 0.001). This finding is buried in papers only made available to US regulators, rather than highlighted in the trial results. The selective exclusion of individuals in trials is an area commonly exploited by drug manufacturers to exaggerate claims. The best evidence conventionally comes from including all randomised subjects (‘intention-to-treat’), whether they deviate from the trial protocol or not. Requests for scrutiny of the trial data, to understand what factors lead to these exclusions, have been ignored.
Since the primary outcome of the trial is related to mild covid-19 events, we know little about whether the vaccine prevents deaths from the virus. Others have indicated that trials will not be sufficiently powered to detect differences in need for hospital treatment, let alone death from covid-19, since the number of subjects and resources required for such a trial would be prohibitive. We cannot assume that prevention of infection translates to fewer deaths. For influenza vaccinations, for example, even though they reduce infection, that has not translated into lower mortality after widespread uptake.
The vaccine has been studied in a healthy population who are largely unaffected by covid-19 hospitalisation or death, even with subjects drawn from supposedly ‘hard-hit’ regions, including the US, Brazil, South Africa, Germany, and Turkey. This trial evidence supports reductions in mild covid-19 infections only. We simply don’t know whether the vaccine will prevent what really matters: hospital and intensive care admissions and deaths.
The trial confirms that for people of working age, the risk of fatality from covid-19 is extremely low. So low in fact, that there will be too few deaths to run a trial without spending an extraordinary amount of money on a very large one. The conclusion by health authorities not to run a trial on vaccine effectiveness to prevent death means they themselves conclude that the fatality risk of the virus, and hence need for a vaccine, is overblown.
New Zealanders are being offered a covid-19 shot with the inaccurate assurance that it is “safe and effective”. From the evidence reviewed here, this message is disingenuous.
The long-term benefits and harms from covid-19 vaccines are unknown since they have only been recently used in humans. This is acknowledged in Medsafe’s 58 conditions for the emergency use. They require early alerts to company reports about the product’s safety and possible benefits. If the government’s own officials are sceptical and demand transparency, we should as well.
We should be concerned
6 April 2021
Like many gravitating to the Covid Plan B webpage, I am increasingly concerned about our government’s and indeed the global approach to the management of the Covid-19 pandemic. There are so many aspects of the present situation that seem so completely surreal.
From the philosophical perspective, I am deeply concerned about the adulteration of the scientific method. Am tired of hearing the media admonish us to trust the science and trust the experts. I constantly need to remind those around me that science is a tool, a method which if correctly applied will answer questions in a meaningful way bringing us progressively closer to an approximation of truth. It is primarily a process of observation and to make our observations meaningful these must be conducted in a carefully controlled manner.
By contrast, the force dominating our present world view is a deceitful yet carefully contrived facsimile of science. It uses all the vestiges, regalia and language of science without meeting the fundamental criteria. The policies and interventions which are being foisted upon us in the name of this pandemic are based not upon controlled observation, but rather upon narratives, rhetoric and data derived from some rather dubious uses of modelling. To make the distinction I will refer to this alternative paradigm of polemics and extrapolation as scientism. It is a sleight of hand, a wolf in sheep’s clothing, the proverbial cuckoo in the nest of the scientific method.
Examples of scientific fraud that have been perpetuated on our populous over the course of the present pandemic are sadly numerous. But I wish to focus here on the novel reversible gene therapy which is being deployed to our New Zealand population under the auspices of the disarming banner of the term “vaccine”. Vaccines are central to our medical approach to the prevention of severe human disease. However, the present technology has never been used for this application on prior occasions. It is disingenuous to include this technology within the trusted envelope of the term “vaccine” without evidence that it is both safe and effective for use in this capacity. The suggestion that an individual’s access to employment, ability to access services and ability to travel could depend upon their participation in this uncontrolled human experiment should be deeply alarming to anyone who places any value on human rights.
I have deep concerns about the speed at which these experimental “vaccines” are being presented as the only solution to the pandemic. No one has been able to answer the question as to how we can be confident that the recurring problem of antibody dependent enhancement which plagued our prior attempts to produce vaccines to other coronavirus variants in animal studies has been overcome. The main safety concern may not lie in the deployment of these “vaccines” but rather in the exuberance of the inflammatory response which follows the subsequent exposure of a patient to covid-19 or a future coronavirus variant.
Science aside, I am alarmed at the campaign of propaganda directed at the public through our mainstream media. The media’s phrasing of Covid-19 is hyperbole at best or worse – blatant fear mongering. By prefixing reports with phrase selection “the deadly virus” it is little wonder that many of our fellow New Zealanders are living in the state of fear that paralyses rational decision making. I am unaccustomed to living in an environment in which rational discussion has become verboten. Never have I seen anybody who dares to ask legitimate questions, shutdown so vehemently and labelled “controversial” or a “conspiracy theorist”.
It seems quite clear that we are only “allowed” to conform to the narrative being presented to us by our government and our trusted mainstream media. We once lived in a free society, with free speech and open dialogue, this no longer seems to be the case. Should we be concerned? I am.
The author: I do not wish to disclose my identity, at least for the time-being. I have undertaken a protracted tertiary education which includes degrees in science (cellular and molecular biology and biochemistry) medicine and dentistry and a doctoral degree with research in molecular biology. I am lucky to be a member of the fortunate educated.
In a speech to her Party Conference today, Prime Minister Jacinda Ardern has effectively ended the nation’s elimination strategy.
Early into the pandemic the Government shifted from policies that might ‘flatten the curve’ of the virus impact, to ones such as “lockdown” which might eliminate the virus in New Zealand. Jacinda Ardern said the strategy was to eliminate the virus. Media named the architect of the strategy as Michael Baker of Otago University. His plan was supported by other academics such as Rod Jackson and Siouxsie Wiles.
Covid Plan B said elimination of the virus from the country was not possible in the long term, and the cost of attempting it – on health, society and economy – was too high. In any case, elimination was not warranted because population health impacts of the virus were comparatively small.
Ardern’s words today acknowledge that Sars-CoV-2 will not be eliminated. Her description of the new goal is similar to those of us who have advocated learning to ‘live with the virus’. The Government’s answer now is a seasonal vaccination programme.
Ardern said that 2021 would be “the year of the vaccine… for the world”. “Our goal has to be though, to get the management of covid-19 to a similar place as we do seasonally with the flu. It won’t be a disease that we will see simply disappear after one round of vaccine across our population. Our goal has to be to put it in a place where as we do every year with a flu vaccination programme that we roll out a vaccine programme and maintain a level of normality in between time.”
A banal report from the Children’s Commissioner about life in lockdown for NZ kids has a few interesting findings when you dig into it.
By and large, it appears that our kids dealt reasonably resiliently with what the report stupidly claims to be “unprecedented times”
From their survey, half of kids’ parents worked at home and half went out to work – that’s a lot different from the “work from home” message that dominated the perspective of the Government.
Only 8% of kids list the public health messages as a memorable feature of the period.
The absolutely dominant feature and commonality among all kids is that they really missed and disliked the physical separation from their friends, particularly via school. That speaks to a reality of the lives of almost all of us – and something denied by lockdown and social distancing: we simply cannot live for very long separated from each other.
26 October 2020
A group of New Zealand health practitioners have joined a growing international movement that says Covid19 is not a sufficient threat to warrant the elimination strategy and lockdowns.
The founding signatories felt obliged by their professional ethics to express support by signing a statement of principles that assert the low risk posed by Covid19, the availability of treatment, the dangers of Government over-reaction, and primacy of the doctor-patient relationship.
Covid Plan B spokesperson Simon Thornley praised the medical practitioners for expressing their views.
“Around the world medical specialists are speaking out. They have seen the data and seen that the initial fear is now clearly unfounded. They are seeing the damage to people’s heath caused by institutional fear and compliance, and by elimination strategies and lockdowns. Unlike too many others, they are prepared to say so.
“Their statement will signal to like-minded New Zealanders in the healthcare sector that they can and should resist, and they should reassure patients and the public.”
The group says its statement was intended to break the silence. It says New Zealand registered health practitioners who want to join the movement should sign the international Great Barrington Declaration and email Covid Plan B (firstname.lastname@example.org).
The Great Barrington Declaration is now supported by over 11,000 medical specialists and over 30,000 medical practitioners.
Contact: Simon Thornley, 021 299 1752
26 October 2020
Registered Health Practitioners for Covid Plan B
Statement of principles
Health is based on freedom and trust. Free human beings can decide themselves about their health.
Free societies decide in democratic discussions how to deal with their health. The NZ Bill of Rights guarantees free choice of treatment.
Fear of the pandemic makes us unfree. It makes us see vaccination and lockdowns as the only way to get back to normality.
International health data and our own experience shows that the fear engendered in the public and our patients is not proportional to the threat to their health posed by covid-19.
Therefore New Zealand’s public health and economic response to covid-19 needs reviewing. It is very likely to be more harmful than the threat posed by the virus in the medium to long term.
Doctors can help. We can develop trust through mutual respect, transparency and democratic debate. We can take action with our patients, so they are healthier and better able to fight infection, and by providing treatments if they fall ill to Covid-19.
There is nothing we have yet seen in the features of this virus that warrants it being regarded as especially dangerous above the many other viruses that are with us every day. The most practical response is the standard precautions of improving personal hygiene, physical health and improving lifestyles.
We want the public to know that the infection fatality rate of Covid-19 is currently about 0.3% once antibody levels are accounted for. The infection fatality rate of influenza, which is strongest each winter, is about 0.1%. It is also clear that the ages of people who die with Covid-19 is about the same as that from natural mortality. This information is enough to inspire us to take better care of our health, but not to drastically change our society and economy.
It is impossible to obtain information about the severity of Covid-19 infections in New Zealand, so we have had to rely on overseas research. About a third of Covid-19 positive patients have no symptoms, with about 90% of infections treated in the community, and only about 1.5% needing intensive care. In the US, almost all hospital treated cases have had other serious medical conditions and are almost all people who die with the virus are over 50 years old. Unusual or long lasting symptoms currently appear similar to a range of responses seen in other respiratory illnesses.
Doctors now have many promising treatments against Covid-19, including easily available supplements like vitamin D. Internationally, the death rate is falling, in part, because we are getting better at treating the disease.
Immune function can benefit from minimising sugar and refined starch intake, eating several servings of fruit and vegetables daily, being physically active, socially connected and having sensible sun exposure to ensure adequate levels of vitamin D, avoiding tobacco and excess alcohol.
We have identified comorbidities that make people susceptible to Covid-19, such as diabetes, hypertension and raised cholesterol. We need to treat a condition in these patients called Metabolic Syndrome, which creates immune system dysfunction.
Decision makers, when assessing health strategies, compare the economic costs of a policy to its benefits. Recent assessments by economists indicate that the costs of lockdowns in New Zealand outweigh benefits by a ratio of between 90 and 200 to one. This indicates that Covid-19 has been disproportionately treated compared to critical health issues that our patients face day-to-day.
Policies that the Government should prioritise or review are:
- Adequate resourcing of high-quality infection control and quality care in rest homes and hospitals to prevent the spread of covid-19 to vulnerable people.
- Abandon the use of lockdowns to contain the virus. Strong evidence now indicates that these measures are disastrous economically and do little to contain viral spread.
- Review the requirement for managed quarantine and compulsory detention for both community and hospital cases in the light of the updated lower fatality risk of the virus. This measure leads to social isolation and undue mental distress.
- Further limits on border travel should be urgently reviewed in the light of a cost-benefit analysis.
- Avoid any measures that lead to social isolation in the response to contain the virus.
- Review the requirement for compulsory diagnostic tests in the light of the lower fatality rate of the virus. We believe that patients should continue to have the right to refuse medical tests, as they do for other procedures, and that the public health risk from this virus does not warrant these rights being superseded.
- Abandon the requirement to wear masks on public transport. We believe that the best epidemiological evidence available does not support mask wearing to reduce the risk of respiratory virus transmission.
- We believe that the doctor-patient relationship should be safe-guarded, along with the ability for doctors to see patients in-person rather than online. Online patient consultations detract from the quality of the doctor-patient relationship and raise the risk of mis-diagnosis.
As facts about the virus become self-evident, the public is wondering whether the current measures cause more harm than good. They will wonder why authorities have been unwilling to listen to, or even allow, discussion of the facts and alternative policies. We are deeply concerned that the consequence will be a loss of faith in health services, science and bureaucracy.
Dr Cindy de Villiers – General Practitioner, M.B.,Ch.B
Dr Matthias Seidel – Obstetrician and Gynaecologist
Dr Anne O’Reilly – General Practitioner. MB BCh FRNZCGP
Dr Rob Maunsell – General Practitioner
Dr René de Monchy – Consultant Psychiatrist
Dr Robin Kelly – General Practitioner MRCS, LRCP, FRNZCGP
Dr Tessa Jones – Integrative medical practitioner MBChB, Dip Obs, FRNZCGP, FACNEM, FABAARM
Dr Alison Goodwin – General Practitioner, MBChB, FRNZCGP
Dr Ronald Goedeke – Director of Appearance Medicine, BSc Hons MBChB
Dr Deon Claassens – General Practitioner, MBChB, Dip. SportsMed, FRNZCGP
Shane Chafin – Pharmacist,AGPP,BCACP
Dr Ulrich Doering – General Practitioner, MBChB, Dipl O&G, FRNZCGP
Dr Samantha Bailey – Research Physician MBChB (Otago)